Enhertu Demonstrates Clinically Meaningful PFS and OS Benefits in HER2-Expressing Solid Tumors in DESTINY-PanTumor02 Trial

On July 27, AstraZeneca and Daiichi Sankyo jointly announced that the primary analysis results of the ongoing Phase II DESTINY-PanTumor02 study showed that Enhertu (trastuzumab deruxtecan) achieved clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) in patients with various HER2-expressing advanced solid tumors who had previously received treatment. These are two secondary endpoints of the study. These data will support current discussions with regulatory authorities worldwide.

DESTINY-PanTumor02 Study is a global, multi-center, open-label, multi-cohort Phase II clinical trial that enrolled a total of 268 patients. It aims to evaluate the efficacy and safety of Enhertu (5.4mg/kg) in patients with locally advanced, unresectable, or metastatic HER2-expressing solid tumors who have received prior treatment. The study includes seven cohorts: biliary tract cancer, urothelial cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare cancers.

In the primary analysis, Enhertu continued to demonstrate durable responses based on the investigator-assessed confirmed objective response rate (ORR) (primary endpoint) and duration of response (DoR) (secondary endpoint), reinforcing the interim analysis results of the trial recently presented at the 2023 ASCO Annual Meeting.

The safety profile observed in the primary analysis was consistent with previous data and other trials of Enhertu, with no new safety issues identified. The incidence and severity of interstitial lung disease (ILD) were consistent with those observed in other trials of Enhertu, and the rate of Grade 5 ILD events, as determined by an independent review committee, was low.

AstraZeneca Chief Medical Officer and Chief Development Officer, Oncology, Cristian Massacesi, said: "The PFS and OS results of Enhertu, along with the continued, robust, and durable tumor responses observed during further follow-up, highlight the potential value of this important drug for patients with HER2-expressing cancers who currently have no targeted treatment options. Given the significant unmet needs of these cancer patients, we are working with health authorities to bring Enhertu as soon as possible to patients with HER2-expressing cancers who may benefit from this drug."

Mark Rutstein, Global Head of Oncology Development at Daiichi Sankyo, stated: "These latest results from the DESTINY-PanTumor02 study are highly significant in reshaping the clinical landscape for HER2-expressing advanced cancers, where treatment options are currently limited and prognosis is poor. The OS benefit demonstrated by Enhertu in these patients represents an important step forward, with the potential to advance current treatment standards and provide new options for patients with HER2-expressing cancers."

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